Prospective Cohort Study Evaluating a Thermal Spa Programme in Symptomatic Knee Osteoarthritis (NCT07534189) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Cohort Study Evaluating a Thermal Spa Programme in Symptomatic Knee Osteoarthritis
France300 participantsStarted 2026-07-01
Plain-language summary
Knee osteoarthritis is a common cause of pain, functional limitation, and reduced quality of life in older adults. Thermal spa treatment is widely used as a non-pharmacological intervention for the management of osteoarthritis symptoms, but its effects on joint movement and motor control remain insufficiently characterized using objective biomechanical measures. This study evaluates the effects of a 3-week thermal spa treatment on knee joint movement in patients with knee osteoarthritis. Knee movement fluidity and gait parameters will be analyzed during standardized tasks using wearable inertial sensors (Xsens). Secondary outcomes include changes in pain, physical function, physical activity, quality of life, and blood transcriptomic profiles. Assessments will be performed at baseline, after treatment, and at 3- and 12-month follow-up visits. In addition, blood samples will be collected before and after the intervention to explore transcriptomic changes associated with the treatment.
This project proposes a combination of innovative kinematic and biological biomarkers with the aim of objectively describing the benefits of spa therapy for people with knee osteoarthritis.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 50 years or older
* Diagnosis of knee osteoarthritis affecting at least one knee, with radiographic Kellgren-Lawrence grade ≥ 2 confirmed by an X-ray performed within the past 3 years
* Average knee pain intensity \> 30 mm on a 100-mm Visual Analog Scale (VAS) during the month prior to inclusion
* Participants scheduled to undergo a 3-week thermal spa treatment at the Balaruc-les-Bains thermal center
Exclusion Criteria:
* Use of systemic or injectable corticosteroids within 1 month prior to inclusion
* Intra-articular injection of hyaluronic acid or platelet-rich plasma (PRP) within the 3 months prior to inclusion
* Active inflammatory joint disease (e.g., rheumatoid arthritis, spondyloarthritis, or crystal-induced arthropathies)
* Current major depressive episode or psychotic disorders
* Thermal spa treatment within the previous 6 months
* Inability to read or write
* Inability to complete follow-up for the entire study period (e.g., planned relocation, travel, professional commitments, or residence located more than 100 km from the study site)
* Lack of informed consent
* Pregnant or breastfeeding women
* Individuals under legal protection (guardianship or curatorship)
* Not affiliated with a national health insurance system
* Individuals under judicial protection (safeguard of justice)
* Participation in another clinical study with an ongoing exclusion period
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.